Tuesday, August 17, 2010

Executive Spotlight: Michael Narachi, President and CEO Orexigen

Michael Narachi joined the Orexigen Therapeutics Inc. management team as president and chief executive officer in March 2009. He has more than 24 years of biotechnology and pharmaceutical experience across a broad range of functions including clinical development, commercialization, strategic business development and planning. Prior to joining Orexigen, Narachi served as chairman, chief executive officer and president of Ren Pharmaceuticals Inc., a private biotechnology company based in South San Francisco, and executive chairman of the board of Naryx Pharma Inc., a private pharmaceutical company located outside of Santa Barbara.Before that, Narachi spent 20 years at Amgen, most recently as an officer and vice president and general manager of the company’s anemia business. He retired in 2004.Narachi received his bachelors’ degree in biology and a master’s in biology and genetics from the University of California at Davis. He also received a master’s in business administration from the Anderson Graduate School of Management at University of California, Los Angeles. He is also chairman of AMAG Pharmaceuticals Inc.

Q: It seems like a dynamic time for the obesity space, in particular for companies like yours working to develop new treatments. We recently heard the Centers for Disease Control and Prevention (CDC) numbers regarding obesity rates among the states, and it’s not looking good. Not a single state met its target for reducing obesity rates, and the number of states reporting rates of 30 percent or more tripled since 2007 to nine states. Where does the problem lie and where does Orexigen fit in?

A: I think that the CDC numbers and the growth of the rates of obesity just point out what people have been reporting on quite a bit in the last year, and that is that we’ve got a big problem here and I think its around both behavior and biology. The way the mechanism of action is designed in Contrave, Orexigen’s obesity drug, is that it tries to impact both behavioral and biological drivers of obesity.

What happens in nature is people are designed to be food seekers and to be rewarded when you find it. For the majority of the evolutionary period here, food has been scarce, and if you didn’t find it, the consequences were severe. So, there are so many mechanisms driving us to find food and then be rewarded when we eat it. People don’t eat just because they’re hungry. We’ve all experienced those meals where you’re full, you’ve got plenty of energy, you’ve got excess storage of energy, and somebody puts something interesting in front of you and you still eat it.

Q: Some people would argue that losing weight is simply a matter of diet and exercise. What do you tell them?

A: We know people are educated and they’re intelligent and they know that having excess body weight in terms of fat is a risk. But diet and exercise alone are not working. It is a cornerstone of what we need to do to be more healthy, but it is not working and there’s this big gap between continually telling people to diet and exercise or, maybe on the other end of the spectrum, people are going and having bariatric surgery. I think what the world is trying to do, or at least pharmacotherapy development companies are trying to do, is develop something in the middle that becomes an enabler to do that diet and exercise cornerstone.

Q: Given what’s already happened in the marketplace with previous failures like Fen-phen (an anti-obesity medication which consisted of two drugs: fenfluramine and phentermine), describe the atmosphere for introducing one of the first prescription products in a decade that could potentially help people safely and effectively lose weight?

A: We look at what happened in the marketplace in the past, particularly when fenfluramine and dexfenfluramine (Redux) were pulled from the market. Once that cardiovascular signal showed up, the FDA does what it normally does, which, if there’s a drug-related signal, takes the drug off the market. That happens in many categories. That happened in Vioxx and Celebrex, too. But that doesn’t mean people stopped working on an anti-inflammatory. And, here, it doesn’t mean people stopped working on treatments for obesity.

The background is that there is a huge unmet need. Obesity is driving all kinds of morbidities and co-morbidities that are costing healthcare systems enormous amounts of money. Diabetes and heart disease alone are huge and there are plenty of drugs that are safe and effective to treat those conditions. We’ve got $30 or $40 billion each for anti-hypertensive meds and Lipitor, for example, and we’ve got the diabetes drugs on top of that. So we’re over $100 billion of useful drugs to treat the conditions that are, in a large part, being driven from obesity. Where we are aiming our therapy is let’s help people lose weight so that we can decrease or even prevent some of those downstream conditions from occurring.

Q: What are your expectations regarding timelines for approval and introduction to the marketplace?

A: Our PDUFA date for the regulatory review for the FDA is January 2011. So the big things on our plate right now are partnership and approval. The partnership and approval is focused on the U.S. Immediately after that we have ex-U.S. partnership. We have our launch and we have our second product, Empatic. Those are the five big things. All of those have enormous implications for the company.

Q: What have you learned about Orexigen since you joined the company early last year?

A: The main thing I’ve learned from joining is just how dedicated the team is here. We’ve really built an excellent team here and people are doing a terrific job. We get questions from the FDA and our turnaround time is fast. We’ve got people at both the leadership and the team level that are very, very skilled and experienced, who have done this before for other companies.

Q: Besides work, where else do you like to spend your time?

A: Well, I’m a surfer, and my family likes to spend time near the ocean. The Channel Islands are a favorite family spot. I also like to spend family time in the mountains. We like to go to really wild backcountry places on my mule and packhorses. We ride mostly in the mountains in the San Rafael wilderness area, up in the Santa Barbara area where we still have a ranch and keep the horses and mules.

Q: If you could meet anyone in the world, who would it be? What would you ask them?

A: Right now, as I’m focused on obesity and healthcare, I’d like to meet the head of Health and Human Services, Kathleen Sebelius. Or, I’d be interested in meeting someone a short time in the future who heads the HHS after we introduce Contrave. Our hope would be that I would ask the question: “Would you ever imagine that we could have this much of a positive impact on healthcare in the United States with obesity therapeutics?” By that time, maybe some of those states would have met their obesity goals.